GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota

About this trial

There are two components to the study: a patient and a clinician study. The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions. The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention. It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases. During active phases, participants will be asked to use the GutCheck app every day. Prior to the first active phase, participants will go through informed consent and app training. The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress. The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms. Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit. The second active phase will last four weeks and will involve the message intervention. A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day. Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 years old

reside in or have received cancer care in Minnesota

own a smartphone • consent to install the GutCheck app and discontinue diet tracking in other lifestyle apps (e.g., MyFitness, Fitbit, Noom).

are English-speaking

Disqualifiers

Unable to participate in an interview

Trial design

Design model

Crossover

Treatments tested in this trial

  • Stool Sample

    Diagnostic test

    Participants who were selected to collect their stool samples will be mailed their second kit before the last week (week 8) of intervention. Participants will collect their stool sample during week 8 and mail them to be processed prior to the Exit Interview Visit.

  • App Activity

    Other intervention

    Participants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Personalization Level - NoActive comparator 2 interventions
Group B: Personalization Level - LowActive comparator 2 interventions
Group C: Personalization Level - HighActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Adherence of Diet Tracking

Average count of days where the participant tracked at least two episodes a day.

Time frame
1 year
2

Adherence of Gastrointestinal (GI) Symptom and Stress Level Tracking

Average count of days of GI symptom and stress tracking combination (i.e., once a day for two weeks for both).

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Minnesota Clinical Trials Network

Collaborator

This trial is not recruiting at the moment. You can still explore other options: